Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, May 29, 2021
Amazon looking at opening pharmacy stores in U.S. - Insider ...
State medical board regulation of compounding in physician ...
Department of Justice
Georgia Man Sentenced to 135 Months’ Imprisonment for Role in Health Care Fraud Scheme Against Tricare
Miami, Florida -- A Georgia man was sentenced yesterday to over 11 years in federal prison for defrauding Tricare of approximately $12 million through a South Florida compounding pharmacy fraud scheme. Tricare is the health care benefit program covering military personnel and their dependents.
According to court documents, 51-year-old Erik Santos and his co-conspirators ran the scheme as follows: Santos paid recruiters to convince Tricare beneficiaries to fill prescriptions for expensive, supposedly tailor-made, compounded medications that the beneficiaries did not need. Santos paid doctors to approve pre-printed prescriptions for large amounts of these medications. The doctors did not see the beneficiaries or otherwise consider their medical needs before approving the prescriptions. Lastly, Santos steered the Tricare beneficiaries to fill their prescriptions with Patient Care America (PCA), a compounding pharmacy located in Broward County, Florida. PCA would bill Tricare for expensive drug formulations that had little to no therapeutic value. Many of the compounded medications were billed to Tricare at $10,000 to $15,000 for a month’s supply, even though the ingredients used in the mixtures were little more than common pain or scar creams. Santos’s fraudulent referrals caused an actual loss to the Tricare program of approximately $12 million. PCA pharmacy paid Santos over $7 million in prescription referral kickbacks.
In addition to the prison sentence, the Court imposed restitution in the amount of $11.8 million and entered a forfeiture judgement of approximately $7.6 million. On January 27, 2021, Santos pled guilty in federal district court in Ft. Lauderdale to one count of conspiring to commit health care fraud and wire fraud.
Acting U.S. Attorney Juan Antonio Gonzalez of the Southern District of Florida, Special Agent in Charge Cynthia A. Bruce of the Defense Criminal Investigative Service (DCIS), Southeast Field Office, and Special Agent in Charge George L. Piro of FBI Miami announced the sentence.
“Criminals steal exorbitant amounts of money from our government health programs through prescription medication fraud schemes. This significant sentence recognizes the seriousness of the crime,” said Acting U.S. Attorney Gonzalez. “Those who use kickbacks and other illegal activity to bilk taxpayer dollars from vital public programs will be held accountable.”
“Billing healthcare programs for medically unnecessary medications not only undermines the viability of those programs, it exploits all citizens,” said DCIS Special Agent in Charge Bruce. “I am pleased with the significant outcome of this investigation and would like to thank the U.S. Attorney’s Office and the investigative team for their tireless effort and great work to hold accountable those who fraudulently bill the Defense Health Agency.”
“Illegal kickbacks undermined the integrity of the Tricare health benefit program by putting profits in front of patient welfare,” said FBI Special Agent in Charge Piro. “The investigators who unraveled this scam are to be commended for their diligence and commitment. The FBI and our partners will continue to pursue those individuals who pay kickbacks and fraudulently bill for medical services that are not necessary.”
DCIS investigated the case with assistance from FBI Miami, and the Food and Drug Administration-Office of Criminal Investigation. The superseding indictment also named CHAMPVA (the Department of Veterans Affairs’ version of Tricare) as a fraud target and the Department of Veterans Affairs-Office of Inspector General assisted with the investigation.
Assistant U.S. Attorney Jon Juenger prosecuted the case. Assistant U.S. Attorney Daren Grove is handling the asset forfeiture component of the case.
A copy of this press release may be found on the website of the United States Attorney’s Office for the Southern District of Florida at www.usdoj.gov/usao/fls.
Related court documents and information may be found on the website of the District Court for the Southern District of Florida at www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov, under case number 20-cr-60089.
Wednesday, May 26, 2021
FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility
Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc.
"Dietary supplements that claim to cure, treat or prevent infertility and other reproductive health conditions can potentially harm consumers who use these products instead of seeking effective treatments, such as FDA-approved drugs or assisted reproductive technology,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. “Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant in warnings about products and companies that place consumers at risk.”
Under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
“Women and families who face fertility issues deserve the best that science has to offer,” said Daniel Kaufman, Acting Director of the FTC’s Bureau of Consumer Protection. “The FTC is proud to work with the FDA to ensure that when companies make claims about fertility treatments and cures, those claims are backed by solid scientific evidence.”
In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
Drugmakers sue HHS over Medicaid drug rebate rule
The Pharmaceutical Research and Manufacturers of America said CMS didn't have the power to issue the rule and seemingly reversed course on the agency's longstanding interpretation of the law.
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Tuesday, May 25, 2021
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UPDATED AGENDA INFORMATION: June 9, 2021: Meeting of ...
|05/25/2021||04/29/2021||Africana Market LLC||Division of Northern Border Imports||Foreign Supplier Verification Program (FSVP)|
|05/25/2021||05/10/2021||Great Lakes Gelatin Company||Office of Human and Animal Food Operations East-VI||New Drug/Misbranded|
|05/25/2021||05/13/2021||Biotek India||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated|
|05/25/2021||05/14/2021||Adirondack Juice LLC d/b/a Adirondack Vapor & Co.||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/25/2021||05/14/2021||Blue Eyed Vapor||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/25/2021||05/19/2021||Smart Women's Choice||Center for Drug Evaluation and Research||Finished Pharmaceuticals/Unapproved New Drug/Misbranded|
|05/21/2021||05/21/2021||Vape Lizard E-Juice LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/20/2021||05/19/2021||BGP, LLC||Center for Drug Evaluation and Research||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|05/20/2021||05/20/2021||Big Chief Vapor Products LLC||Center for Tobacco ProductsVIA UPS||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||04/21/2021||North American Hirudin Biotech Products Inc.||Office of Regulatory Affairs||New Drug/Misbranded|
Saturday, May 22, 2021
Indiana Tax Court Upholds Pharmacy Benefit Management Costs of Performance Approach Friday, May 21, 2021
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FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom. The dietary supplements are manufactured by Atofil, LLC, which is located in Fort Myers, Florida, and is a subsidiary of Premier Manufacturing Products. The dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo. The seized products are worth approximately $1.3 million.
“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” said Judy McMeekin, Pharm.D., the FDA’s Associate Commissioner for Regulatory Affairs. “The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.
In February 2014, the FDA issued an import alert that provides information to FDA field staff about detaining without physical examination imported dietary supplements and bulk dietary ingredients that are or contain kratom.
The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Middle District of Florida alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.
The FDA continues to warn consumers not to use any products labeled as containing kratom. The FDA encourages health care professionals and consumers to report any adverse events related to products containing kratom to the FDA’s MedWatch program by:
- completing and submitting the report online at www.fda.gov/medwatch; or
Tuesday, May 18, 2021
|05/18/2021||05/07/2021||Nicotine Nirvana||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/12/2021||05/04/2021||Baltimore Beauty Security Square Mall||Center for Devices and Radiological Health||Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|05/18/2021||04/21/2021||North American Hirudin Biotech Products Inc.||Office of Regulatory Affairs||New Drug/Misbranded|
|05/18/2021||04/27/2021||NeuroHydrate LLC||Office of Human and Animal Food Operations East – Division 1||New Drug/Misbranded|
|05/18/2021||04/29/2021||Wismettac Asian Foods, Inc.||Division of West Coast Imports||Foreign Supplier Verification Program (FSVP)|
|05/18/2021||05/05/2021||Bio-Botanica, Inc./Nature’s Answer, Inc.||Office of Human and Animal Food Operations East – Division 1||Dietary Supplement/Adulterated/Cesium Chloride|
|05/18/2021||05/07/2021||High Voltage Vaporz LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||05/07/2021||Central Iowa Electronic Cigarettes Inc||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||05/07/2021||Sema International Inc.||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||05/07/2021||The Iron Crow LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||05/07/2021||JP & SN Enterprises Inc. d/b/a eCigs International||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|05/18/2021||05/07/2021||FF Vapors, LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|